Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392677
First received: July 11, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.


Condition Intervention Phase
Type 2 Diabetes Mellitus
High HbA1c Level
Inadequate Glycaemic Control
Drug: dapagliflozin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in HbA1c Levels [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in FPG [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo

  • Adjusted Mean Change From Baseline in Total Body Weight [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo

  • Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
    To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo

  • Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]
    To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo


Enrollment: 311
Study Start Date: October 2011
Study Completion Date: August 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin 10 mg tablet Drug: dapagliflozin
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
Placebo Comparator: matching placebo tablet Drug: placebo
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Men or women age ≥ 18 years old
  • Stable dose combination of metformin and sulfonylurea
  • HbA1c ≥7.7% and ≤11.0%

Exclusion Criteria:

  • Type 1 diabetes mellitus or diabetes insipidus
  • Recent cardiovascular events
  • Kidney or urological disorders
  • Hepatic disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392677

  Show 47 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Eva Johnsson, PhD, Medical Science Director AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden
Principal Investigator: Stephan Matthaei, Prof.Dr.med Diabetes-Zentrum Quakenbruck
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01392677     History of Changes
Other Study ID Numbers: D1693C00005
Study First Received: July 11, 2011
Results First Received: November 5, 2013
Last Updated: February 11, 2014
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
dapagliflozin
diabetes
hyperglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014